Table 4.
Comparison of baseline-adjusted PK parameters based on FIX activity in 50 IU/kg rIX-FP, pdFIX, and rFIX
| PK parameter | rIX-FP (n = 8) | rFIX (n = 8) | rIX-FP/ rFIX ratio | 95% lower CI | 95% upper CI | P | rIX-FP (n = 4) | pdFIX (n = 4) | rIX-FP/pdFIX ratio | 95% lower CI | 95% upper CI | P |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AUC0-inf h × IU/dL | 7142 | 965 | 7.40 | 6.27 | 8.74 | < .0001 | 6661 | 1070 | 6.23 | 4.93 | 7.87 | < .0001 |
| IR, IU/dL per IU/kg | 1.32 | 0.92 | 1.44 | 1.25 | 1.65 | .0002 | 1.40 | 1.08 | 1.29 | 1.06 | 1.57 | .0145 |
| Half-life, h | 89.88 | 17.10 | 5.26 | 4.20 | 6.59 | < .0001 | 84.73 | 14.51 | 5.84 | 4.25 | 8.03 | < .0001 |
| CL, mL/h per kg | 0.71 | 5.18 | 0.14 | 0.12 | 0.16 | < .0001 | 0.74 | 4.67 | 0.16 | 0.12 | 0.20 | < .0001 |
| MRT, h | 128.87 | 24.90 | 5.17 | 4.29 | 6.24 | < .0001 | 116.83 | 21.01 | 5.56 | 4.26 | 7.25 | < .0001 |
| Vz, mL/kg | 0.92 | 1.28 | 0.72 | 0.59 | 0.87 | .0037 | 0.90 | 0.98 | 0.92 | 0.70 | 1.21 | .513 |
The estimated means, ratio of treatment differences, and 95% CI about the ratios are presented for rIX-FP compared with rFIX and to pdFIX as matched pairs. One subject from rIX-FP 50-IU/kg PK population was excluded from the analysis because of the lack of evaluable PK results for the previous FIX product resulting from the occurrence of a bleeding event.